Rationale, study design and methodology of the hypertension registry: a Pan-India, prospective, longitudinal study to assess management and real-world outcomes of high-risk essential hypertension
Background: India contributes significantly towards a large part of the worldwide epidemic of hypertension (HTN) and its associated complications. As, there are limited longitudinal studies available in India to understand its occurrence over time, this Pan-India longitudinal study will aid to assess the real world outcomes of HTN across the country.
Methods: This was a prospective, multi-centered, longitudinal, observational study investigating a large COHORT of people with HTN across India over a period of one year. The primary objective of this study was to evaluate blood pressure (BP) control and clinical outcomes in high-risk hypertensive patients distributed over 5 visits (including baseline visit). The secondary objective is to assess the co-morbidities/risk factors in different clinical settings across India. Participants (4,000) with HTN will be included from 200 centres across India and data will be recorded for the use of anti-hypertensives, demographics, socio-economic status, anthropometric measurements, family history, personal history, risk factors, co-morbid conditions and physician treatment preferences. Overall, clinical practice patterns were assessed for their relationship with clinical outcomes.
Conclusions: This study is expected to reveal the trends in complications associated with HTN, treatment strategies used by physicians, and correlation among treatment, control and complications of HTN within the Indian context. The outcome of this study will help to identify the burden of HTN, along with pin-pointing the emergence of early-onset complications and dose titration patterns. This will eventually help to develop person-centred care and facilitate public health agencies to invest appropriate resources in the management of high-risk HTN across India.
Trial registration: Since this is a real world evidence study no trial registration was needed as per Indian regulations.
Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2224-60.
Thankappan KR, Sivasankaran S, Sarma PS, Mini G, Khader SA, Padmanabhan P, et al. Prevalence-correlates-awareness-treatment and control of hypertension in kumarakom, kerala: baseline results of a community-based intervention program. Indian Heart J. 2006;58(1):28-33.
Das SK, Sanyal K, Basu A. Study of urban community survey in India: growing trend of high prevalence of hypertension in a developing country. Int J Med Sci. 2005;2(2):70-8.
WHO. Fact sheet: Noncommunicable diseases country profiles, 2011. Available at: https://www.who.int/nmh/publications/ncd_profiles2011/en/. Accessed on 5 May 2021.
Hypertension Study Group. Prevalence, awareness, treatment and control of hypertension among the elderly in Bangladesh and India: a multicentre study. Bull World Health Organ. 2001;79(6):490-500.
Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet (London, England). 2005;365(9455):217-23.
Geldsetzer P, Manne-Goehler J, Theilmann M, Davies JI, Awasthi A, Vollmer S, et al. Diabetes and Hypertension in India: A Nationally Representative Study of 1.3 Million Adults. JAMA Intern Med. 2018;178(3):363-72.
Bhise MD, Patra S. Prevalence and correlates of hypertension in Maharashtra, India: a multilevel analysis. PloS One. 2018;13(12):0191948.
Williams B, Mancia G, Spiering W, Rosei EA, Azizi M, Burnier M, et al. 2018 practice guidelines for the management of arterial hypertension of the European society of hypertension and the European society of cardiology: ESH/ESC task force for the management of arterial hypertension. J Hypertens. 2018;36(12):2284-309.
Cuspidi C, Tadic M, Grassi G, Mancia G. Treatment of hypertension: The ESH/ESC guidelines recommendations. Pharmacol Res. 2018;128:315-21.
Shah SN, Munjal YP, Kamath SA, Wander GS, Mehta N, Mukherjee S, et al. Indian guidelines on hypertension-IV (2019). J Hum Hypertens. 2020;34(11):745-58.
Anchala R, Kannuri NK, Pant H, Khan H, Franco OH, Angelantonio ED, et al. Hypertension in India: a systematic review and meta-analysis of prevalence, awareness, and control of hypertension. J Hypertens. 2014;32(6):1170-7.
WHO. Fact sheet: BMI Classification. Global Database on Body Mass Index, 2006. Available at: https://web.archive.org/web/20090418042851/http://www.who.int/bmi/index.jsp?introPage=intro_3.htm. Accessed on 5 May 2021.
Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, et al. Resistant hypertension: diagnosis, evaluation, and treatment. A scientific statement from the American heart association professional education committee of the council for high blood pressure research. Hypertension. 2008;51:1403-19.
Gupta R, Guptha S. Strategies for initial management of hypertension. Indian J Med Res. 2010;132(5):531-42.
Association of Physicians of India. Indian guidelines on hypertension (I.G.H.)-III. 2013. J Assoc Physicians India. 2013;61(2):6-36.
Williams B, Mancia G, Spiering W, Rosei EA, Azizi M, Burnier M, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European society of cardiology and the European society of hypertension: the task force for the management of arterial hypertension of the European society of cardiology and the European society of hypertension. J Hypertens. 2018;36(10):1953-2041.
Chatterjee S, Chattopadhyay S, Hope-Ross M, Lip PL. Hypertension and the eye: changing perspectives. J Hum Hypertens. 2002;16(10):667-75.
Hart PD, Bakris GL. Hypertensive nephropathy: prevention and treatment recommendations. Expert Opin Pharmacother. 2010;11(16):2675-86.
Edwards L, Ring C, McIntyre D, Winer JB, Martin U. Cutaneous sensibility and peripheral nerve function in patients with unmedicated essential hypertension. Psychophysiology. 2008;45(1):141-7.
Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, et al. Executive group on behalf of the joint European Society of cardiology (ESC)/American college of cardiology (ACC)/American heart association (AHA)/world heart federation (WHF) task force for the universal definition of myocardial infarction. Fourth universal definition of myocardial infarction. J Am Coll Cardiol. 2018;72:2231-64.
Kumar A, Cannon CP. Acute coronary syndromes: diagnosis and management, part I. Mayo Clin Proc. 2009;84(10):917-38.
Musuka TD, Wilton SB, Traboulsi M, Hill MD. Diagnosis and management of acute ischemic stroke: speed is critical. CMAJ. 2015;187(12):887-93.
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, et al. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: the task force for the diagnosis and treatment of acute and chronic heart failure of the European society of cardiology (ESC). Developed with the special contribution of the heart failure association (HFA) of the ESC. Eur J Heart Fail. 2016;37(27):2129-200.
Olin JW, Sealove BA. Peripheral artery disease: current insight into the disease and its diagnosis and management. Mayo Clin Proc. 2010;85(7):678-92